EP1152781A1 - Blood-related dialysis and treatment - Google Patents
Blood-related dialysis and treatmentInfo
- Publication number
- EP1152781A1 EP1152781A1 EP99969212A EP99969212A EP1152781A1 EP 1152781 A1 EP1152781 A1 EP 1152781A1 EP 99969212 A EP99969212 A EP 99969212A EP 99969212 A EP99969212 A EP 99969212A EP 1152781 A1 EP1152781 A1 EP 1152781A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- plasma
- blood
- solvent stream
- membrane
- removal
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/42—Electrodialysis; Electro-osmosis ; Electro-ultrafiltration; Membrane capacitive deionization
- B01D61/425—Electro-ultrafiltration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M1/3403—Regulation parameters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M1/3403—Regulation parameters
- A61M1/3406—Physical characteristics of the filtrate, e.g. urea
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D57/00—Separation, other than separation of solids, not fully covered by a single other group or subclass, e.g. B03C
- B01D57/02—Separation, other than separation of solids, not fully covered by a single other group or subclass, e.g. B03C by electrophoresis
Definitions
- the present invention relates to methods suitable for treating or processing blood or plasma to remove or reduce the concentration of unwanted components, and particularly dialysis methods applicable to renal dialysis.
- the kidney functions to remove excess water, salts and small proteins from the blood circulation.
- Nitrogenous wastes removed by the kidney include urea, the final metabolic destiny of excess dietary nitrogen, creatinine which is produced during muscle activity, and uric acid, an endpoint product of nucleotide metabolism.
- Current renal dialysis technology relies on equilibrium diffusion principles and transmembrane pressure to remove nitrogenous wastes, salts and excess water from the bloodstream of patients experiencing chronic or acute renal failure. This requires two to three hours of dialysis treatment on three or four occasions each week.
- the demonstrated protein separation capacity of the GradiFlow technology can be applied to the removal of specific proteins from the blood or plasma circulations, with the intention of treating disease symptoms mediated by those proteins.
- diseases states include rheumatoid arthritis and a host of other autoantibody mediated autoimmune diseases, which could be treated by the selective removal of autoantibody or other disease related proteins from the patients blood circulation.
- the present inventois have developed a device based on GradiFlow technology (AU 601040) which can be used to selectively remove solutes, metabolites and pioteins from either blood or plasma
- a device can be used as either an add-on module to existing dialysis machines, or as a stand - alone device used to filter the blood of dialysis patients as a specific therapeutic measure to remove metabolites and proteins after conventional dialysis therapy has already been applied
- the Gradiflow can be re-configured so that dialysis of a mixture of components is possible
- dialysis is a therapy which eliminates the toxic wastes from the body due to kidney failure
- haemodialysis haemodialysis
- Haemodialysis is usually performed in dialysis centers, where the tieatment entails dialysis for 4 hours three times a week This sharply interferes with the quality of life of patients and also their productivity to the community at large
- the present technology entails the re-routing of blood from the body to a filter made of plastic capillaries The blood is purified when the waste products diffuse from the blood across the membrane of these tiny capillaries The blood is then return to the body via the arm
- the mam advantage to this system is that patient training is not required
- the main disadvantages are that dialysis graft failure is common and there is lack of fieedom on the part of the patient because of the requirement to report to a center for treatment
- the Gradiflow is a unique preparative electrophoresis technology for macromolecule separation which utilises tangential flow across a polyacrylamide membrane when a charge is applied across the membrane.
- the general design of the Gradiflow system facilitates the purification of proteins and other macromolecules under near native conditions. This results in higher yields and excellent recovery.
- the Gradiflow technology is bundled into a cartridge comprising of three membranes housed in a system of specially engineered grids and gaskets which allow separation of macromolecules by charge and/or molecular weight.
- the system can also concentrate and desalt/dialyse at the same time.
- the multimodal nature of the system allows this technology to be used in a number of other areas especially in therapy for the dialysis of blood in situations like renal failure.
- the configuration of the Gradiflow apparatus allows the possibility of producing a simple portable device which will have the dual capacity of being easy to use and concurrently producing high quality dialysis.
- the present invention consists in use of Gradiflow in the processing of blood or plasma from a subject in order to remove or reduce the concentration of unwanted solutes and macromolecules from the blood or plasma.
- Gradiflow is used in renal dialysis, either as a replacement of current dialysis methods or as a supplement to current renal dialysis.
- the present invention consists in a method of treating blood or plasma of a subject to remove or reduce the concentration of metabolic contaminants, the method comprising:
- step (d) maintaining step (b). and optionally step (c) if used, until the desired amount of removal of the metabolic contaminants from the blood or plasma in the first solvent stream is achieved;
- the subject is a renal dialysis patient
- the blood or plasma is preferably recirculated between the subject and the first solvent stream
- the electrophoretic membrane has a molecular mass cut-off close to the apparent molecular mass of metabolic contaminants. It will be appreciated, however, that the membrane may have any required molecular mass cut-off depending on the application
- the metabolic contaminants are solutes including phosphates, nitrogenous wastes like urea and uric acid, or macromolecules including beta-2 microglobuhn and other unwanted proteins including autoantibodies
- the electrophoretic membrane has a molecular mass cut-off of between about 3 and lOOOkDa It will be appreciated, however, that other size membranes may be applicable, depending on the treatment process required A number of different membranes may also be used in a desired or useful configuration
- the electric potential applied during the method should preferably not substantially adversely effect the cells or proteins present in blood or plasma An electric potential of up to about 100 volts has been found to be suitable It will be appieciated. however, that other voltages may be used
- the present invention consists in a method of renal dialysis, the method comprising carrying out haemodialysis on blood or plasma of a patient followed bv subjecting the blood or plasma of the patient to the method accoiding to the second aspect of the present invention
- the method comprises
- step (e) maintaining step (c), and optionally step (d) if used, until the desired amount of removal or reduction of the metabolic contaminants from the blood oi plasma in the first solvent stream is achieved, and
- the contaminants can be phosphates or proteins such as beta-2 macoglobuhn or autoantibodies It will be appreciated, however, that other unwanted metabolic contaminants can also be removed in this process
- Creatinine removal is dependent on pH, with lower pH conditions resulting in more rapid removal of creatinine from aqueous solutions.
- Figure 9 Increasing the size of the membrane molecular mass cutoff value allowed creatinine removal to proceed at a progressively faster rate.
- Figure 18 Phosphate was rapidly removed from plasma using a 50V electric potential.
- Figure 19 Native PAGE analysis of proteins removed from whole blood using the GradiFlow system. Lanes 1 and 10 are molecular weight markers, with size in kDa shown at the right side. Lane 2 is diluted plasma.
- Lane 3 is red cell lysate, predominantly haemoglobin.
- Lane 4 shows albumin and other smaller proteins removed from blood that had been passed through the GradiFlow 10 times with an applied voltage of 50V at 4C.
- Lanes 5 and 6 show proteins removed from blood using 100V at 4C after 5 and 10 passes respectively.
- Lanes 7,8 and 9 show proteins removed from whole blood after
- FIG. 20 The accumulation of protein removed from plasma.
- the triangles indicate the A280 (total protein absorbance) in the downstream.
- the squares indicate the relative amount of beta-2 microglobulin in the downstream.
- the data m Figure 1 show the concentration of Urea in the upstream (solid squares) and in the downstream (hatched squares).
- the concentration of Urea in the upstream decreased over time, while the concentration of urea in the downstream increased. This result indicates that urea can be removed from aqueous solution by passive diffusion. Removal of Urea from plasma Method
- Unmodified human plasma or human plasma to which lmg/mL Urea had been added, was placed in the upstream of a GradiFlow device.
- PBS buffer chilled to 4°C with ice, was recirculated in the buffer stream.
- the up and down streams were pumped through the GradiFlow device at 20mL/min and samples taken from both streams at 10 minute intervals. No voltage or current was applied during this procedure. The timed samples were then assayed for urea content.
- the data in Figure 2 show the concentration of endogenous Urea in the upstream (solid diamonds) and in the downstream (hatched diamonds) when unmodified plasma was used in this experiment.
- the concentration of Urea in the upstream and downstream when exogenous Urea was added to the sample is shown in red squares and pink triangles respectively.
- concentration of Urea in the upstream decreased over time, while the concentration of urea in the downstream increased. This result indicates that urea may be removed from plasma by passive diffusion.
- Urea was dissolved in an appropriate buffer and placed in the sample stream of a GradiFlow device, with the GradiFlow cartridge constructed in dialysis configuration.
- the circulating buffer stream was selected to match the solution in which Urea had been dissolved.
- the starting Urea concentration, buffer pH. salt concentration, temperature of the system and applied voltage/current were varied systematically to determine the effect each variable had on the rate of Urea removal.
- the Urea solution was pumped through the GradiFlow device at 20mL/min, with samples generally being taken at 10 minute intervals The timed samples were then assaved for uiea content
- Figure 6 shows that Creatinine was rapidly removed from the upstream of the GiadiFlow instrument at 25V Creatinine entered the downstream of the GiadiFlow. but was not retained by the 3kDa restriction membrane, so the downstieam concentration was also rapidly depleted Factors affecting creatinine removal m the GradiFlow Method
- Creatinine was dissolved in an appropriate buffer and placed in the sample stream of a GradiFlow device, with the GradiFlow cartridge constructed m dialysis configuration
- the circulating buffer stream was selected to match the solution in which creatinine had been dissolved
- the buffer pH. salt concentration, tempeiature of the system and applied voltage/current were varied systematically to determine the effect each variable had on the rate of creatinine removal
- the creatinine solution was pumped through the GradiFlow device at 20mL/m ⁇ n, with samples generally being taken at 5 minute intervals The timed samples were then assayed for creatinine content
- Creatinine removal is dependent on pH, with lower pH conditions resulting in more rapid removal of creatinine from aqueous solutions The effect of voltage on Creatinine removal
- Figure 8 shows the application of increasing voltage in the GradiFlow system accelerated the removal of creatinine from the sample stream.
- Figure 9 shows increasing the size of the membrane molecular mass cutoff value allowed creatinine removal to proceed at a progressively faster rate
- Hepes Imidazole buffer chilled to 4C. was recirculated in the buffer stream of the GradiFlow device.
- the membrane cartridge used included 3kDa restriction membranes and a 50kDa separation membrane.
- FIG 11 shows that Uric acid was rapidly removed from the upstream, passing through the downstream to reach the buffer stream.
- Uric acid was dissolved in an appropriate buffer and placed in the sample stream of a GradiFlow device, with the GradiFlow cartridge constructed in dialysis configuration.
- the circulating buffer stream was selected to match the solution in which uric acid had been dissolved.
- the membrane pore size, salt concentration, temperature of the system and applied voltage/current were varied systematically to determine the effect each variable had on the late of uric acid removal
- the uric acid solution was pumped through the GradiFlow device at 20mL/m ⁇ n, with samples geneially being taken at 5 minute intervals The timed samples were then assayed for uric acid content
- Figure 13 shows increasing the molecular mass cutoff of the GradiFlow membranes resulted in more rapid removal of Uric acid from the sample stream The effect of NaCl on Uric acid removal
- Figuie 14 shows that the addition of NaCl caused a dose-dependent deciease in the rate of uric acid removal
- HSA human serum albumin
- Beta-2 microglobuhn is a normal component of MHC Class I molecules, which are found on the surface of all nucleated cells This protein is frequently released in to the blood circulation during episodes of immunological activity such as infections
- Normal plasma contains very low concentrations of beta-2 microglobuhn. in the order of 3 ⁇ g/mL. This concentration is laised in lenal dialysis patients, firstly due to the increased frequency of infections experienced when on dialysis, and secondly due to the poor capacity of conventional renal dialysis technology to remove this protein As a result of the inability of conventional renal replacement therapy to remove beta-2 microglobuhn.
- beta-2 microglobuhn the concentration of this protein increases in the blood circulation of renal dialysis patients.
- beta-2 microglobuhn amyloid fibrils in the bones and other tissues of lenal dialysis patients which affects bone structure and bone manow function
- the present inventors have tested the ability of the GradiFlow to lemove beta-2 microglobuhn from normal human plasma Forty mL of plasma was diluted 1 1 in T ⁇ s/borate buffer pH 9 and processed in the
- Cieatinine is a charged nitrogenous waste material which has been shown to be removed from plasma, and whose rate of removal has been shown to be dependent on voltage. pH, salt concentration, temperature and membiane pore size The capacity of the GradiFlow system to rapidly lemove charged nitrogenous wastes is significant to the GradiFlow capacity in lenal dialysis
- Unc acid was removed fiom aqueous solutions and from plasma Removal of Uric acid was shown to be dependent on voltage, membrane pore size temperature and salt concentration Uric acid removal is another example of electrically driven dialysis which allows rapid removal of mtiogenous wastes from plasma
- the GradiFlow system is useful foi the removal of nitrogenous wastes, phosphate ions, and proteins such as albumin and beta-2 microglobuhn, from aqueous solutions, plasma and blood
- the ability to remove waste or unwanted materials from blood or plasma by the simultaneous use of diffusive and electrophoretic principles in a single caitndge system is an advantage
- urea can be removed on the basis of latent diffusion while other waste materials can be removed on the basis of charge during the same process
- the capacity of the basic GradiFlow system to perform these functions indicates the potential applications of the GradiFlow system in the field of renal dialysis and other blood purification applications which require the selective removal of proteins and other charged or uncharged species from circulating blood or plasma
- Modified versions of the GradiFlow device can be constructed which could be used either as a complete renal dialysis device, addressing all lenal replacement therapy needs including removal of salts, phosphate, nitrogenous wastes, excess water balancing blood pH and removing beta-2 microglobuhn
Abstract
Description
Claims
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AUPP790898 | 1998-12-23 | ||
AUPP7908A AUPP790898A0 (en) | 1998-12-23 | 1998-12-23 | Renal dialysis |
PCT/AU1999/001172 WO2000038759A1 (en) | 1998-12-23 | 1999-12-23 | Blood-related dialysis and treatment |
Publications (2)
Publication Number | Publication Date |
---|---|
EP1152781A1 true EP1152781A1 (en) | 2001-11-14 |
EP1152781A4 EP1152781A4 (en) | 2004-11-17 |
Family
ID=3812115
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP99969212A Withdrawn EP1152781A4 (en) | 1998-12-23 | 1999-12-23 | Blood-related dialysis and treatment |
Country Status (7)
Country | Link |
---|---|
US (1) | US6855121B1 (en) |
EP (1) | EP1152781A4 (en) |
JP (2) | JP2002533168A (en) |
AU (1) | AUPP790898A0 (en) |
CA (1) | CA2356562A1 (en) |
HK (1) | HK1045269A1 (en) |
WO (1) | WO2000038759A1 (en) |
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EP1474688A1 (en) * | 2002-02-14 | 2004-11-10 | Millipore Corporation | Diluent, methods of manufacture and use |
JP4416797B2 (en) * | 2003-11-07 | 2010-02-17 | ネクステージ メディカル インコーポレイテッド | Improved method and apparatus for leak detection in blood processing systems |
US10626399B2 (en) | 2010-01-28 | 2020-04-21 | The Board Of Trustees Of The Leland Stanford Junior University | Methods of treating cognitive symptoms of an aging-associated impairment by modulating C-C chemokine receptor type 3 (CCR3) |
US20160208011A1 (en) | 2010-01-28 | 2016-07-21 | The Board Of Trustees Of The Leland Stanford Junior University | Ccr3 modulation in the treatment of aging-associated impairments, and compositions for practicing the same |
US10487148B2 (en) | 2010-01-28 | 2019-11-26 | The Board Of Trustees Of The Leland Stanford Junior University | Methods and compositions for treating aging-associated impairments |
CA2796505C (en) * | 2010-04-16 | 2018-12-11 | Baxter International Inc. | Therapy prediction and optimization for renal failure blood therapy, especially home hemodialysis |
US8868350B2 (en) | 2010-04-16 | 2014-10-21 | Baxter International Inc. | Therapy prediction and optimization for renal failure blood therapy, especially home hemodialysis |
US9132219B2 (en) | 2010-04-16 | 2015-09-15 | Baxter International Inc. | Therapy prediction and optimization of serum potassium for renal failure blood therapy, especially home hemodialysis |
US9161968B2 (en) | 2011-04-08 | 2015-10-20 | The Board Of Trustees Of The Leland Stanford Junior University | Methods of neuroprotection involving macrophage colony stimulating factor receptor agonists |
US10905779B2 (en) | 2013-12-09 | 2021-02-02 | The Board Of Trustees Of The Leland Stanford Junior University | Methods for screening human blood products comprising plasma using immunocompromised rodent models |
KR102155857B1 (en) | 2013-12-09 | 2020-09-15 | 더 보드 어브 트러스티스 어브 더 리랜드 스탠포드 주니어 유니버시티 | Methods and compositions for treating aging-associated conditions |
CN107921188A (en) | 2015-05-18 | 2018-04-17 | 小利兰·斯坦福大学托管委员会 | For treating the method and composition of the relevant damage of aging |
JP6921006B2 (en) | 2015-06-15 | 2021-08-18 | ザ ボード オブ トラスティーズ オブ ザ レランド スタンフォード ジュニア ユニバーシティー | Methods and compositions for treating aging-related symptoms |
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- 1999-12-23 US US09/470,822 patent/US6855121B1/en not_active Expired - Fee Related
- 1999-12-23 JP JP2000590709A patent/JP2002533168A/en active Pending
- 1999-12-23 CA CA002356562A patent/CA2356562A1/en not_active Abandoned
- 1999-12-23 EP EP99969212A patent/EP1152781A4/en not_active Withdrawn
-
2002
- 2002-05-10 HK HK02103564.8A patent/HK1045269A1/en unknown
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2008
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Also Published As
Publication number | Publication date |
---|---|
JP2009056323A (en) | 2009-03-19 |
EP1152781A4 (en) | 2004-11-17 |
AUPP790898A0 (en) | 1999-01-28 |
HK1045269A1 (en) | 2002-11-22 |
WO2000038759A1 (en) | 2000-07-06 |
CA2356562A1 (en) | 2000-07-06 |
JP2002533168A (en) | 2002-10-08 |
US6855121B1 (en) | 2005-02-15 |
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